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Advances in bioinformatics and genomic data analysis have enabled the identification of cancer antigens that are generally overlooked during immune surveillance; these neoantigens have been shown to possess substantial therapeutic potential

The use of neoantigens in therapy has demonstrated the ability to elicit a strong T cell mediated immune response. Several therapy candidates are being investigated both as monotherapies and in combination with various immune checkpoint inhibitors, such as atezolizumab, durvalumab, ipilimumab, and nivolumab. Of these, certain pipeline candidates have already entered mid to late-stage (phase II and above) trials and are anticipated to enter the market over the next 5-10 years.

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Key Market Insights

Over 150+ candidate therapies in the development pipeline

Nearly 13% of the pipeline therapies are being developed for the treatment of GI cancers, followed by lung cancer (11%). Examples of molecules being developed for the aforementioned indications include (in alphabetical order, no specific selection criteria) MicOryx, NCI-4650, and Tedopi®.

1,100+ patents filed / granted in 2018

In fact, more than 6,000 patents were filed / granted related to neoantigen targeted therapies, since 1978. Based on existing intellectual property, the R&D activity was observed to be concentrated in the US. Other key regions with significant intellectual capital include (in decreasing order of number of patents filed / granted) Australia, Europe, China, and Canada.

Close to USD 7.5 billion invested by both private and public investors, since 2014

Around USD 3,200 million was raised through venture capital financing, representing around 43% of the total capital raised by industry players in the given time period (till April 2019). Further, in the last five years, there have been 10 IPOs accounting for more than 800 million in financing of neoantigen related initiatives.

Companies are collaborating actively for the advancement of clinical trials

Majority of the abovementioned agreements were observed to be focused on conducting Phase I / Phase II clinical studies of neoantigen targeted therapies for the treatment of different cancer indications. Agreements signed for research purposes (19%) were also observed to be popular among industry stakeholders, during 2014-2019 (till April).

More than 350 publications have been published since 2014

It is worth noting that between the period 2014-2019, over 150 research articles were published related to neoantigen targeted therapies. Further, more than 190 review articles have been published related to this upcoming field.

Therapies using personalized neoantigens are anticipated to increase at a CAGR of over 60% between 2024 and 2030

This growth is anticipated to be primarily driven by the reduced risk of adverse effects and improved efficacy of personalized therapies. North America (primarily the US) and Europe are expected to capture the majority share by 2030, in terms of the sales-based revenues.

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Key Questions Answered

What are the prevalent trends related to R&D activity focused on neoantigen based therapies?

What are the clinical conditions for which neoantigen targeted therapies are being developed?

What are the key challenges faced by neoantigen-based therapy developed?

Who are the leading industry and non-industry players?

What are the key factors that are likely to influence the evolution of the neoantigen targeted therapies market?

What are the reasons for partnership activity among stakeholders in this industry?

Who are the key investors in neoantigen targeted therapies?

What is share of neoantigen targeted therapies in the immunotherapy market?

How is the current and future market opportunity likely to be distributed across key market segments and geographies?

The USD 3 billion (by 2030) financial opportunity within the neoantigens market has been analyzed across the following segments:

Type of target disease indication

Bone cancer

Colorectal cancer

Gynecological cancer

Non-small cell lung cancer

Renal cell carcinoma

Other cancers

Type of neoantigens

Personalized neoantigens

Off-the-shelf neoantigens

Type of immunotherapy

Dendritic cell vaccines

DNA / RNA-based vaccines

Protein / peptide-based vaccines

TIL-based therapies

Route of administration

Intradermal

Intravenous

Subcutaneous

Other routes

Key geographical regions

North America

Europe

Rest of the World

The report features inputs from eminent industry stakeholders, according to whom neoantigen targeted therapies are expected to be the next big step in cancer immunotherapy. Similar to CAR-T cell therapies, these therapies have, so far, demonstrated significant therapeutic potential and promising clinical outcomes. The report includes detailed transcripts of discussions held with the following experts:

Gabriel Nistor (Chief Science Officer, AIVITA Biomedical)

Ella Sorani (Vice President Research and Development, BioLineRx)

Heinz Lubenau (Chief Operating Officer & Co-founder, VAXIMM)

The research covers detailed profiles, featuring an overview of the company, its financial information (if available), and a description of its product(s), highlighting type of therapy, current development status, and key preclinical / clinical trial results. Each profile also includes a list of recent developments, and an informed opinion on the likely strategies that may be adopted by these players to fuel growth in the foreseen future.

We want to thank the many editors, contributors, and reviewers that helped make this journal a leading publication in its field. We also want to thank you, the readers, for giving our efforts purpose and meaning. It has been a privilege serving you through our printed edition and online.